A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement

NCT ID: NCT00208403

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-10-31

Brief Summary

The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined

Conditions

Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Acryloc™ GHV

Group Type: ACTIVE_COMPARATOR

Acryloc™ GHV

Intervention Type: DEVICE

A high viscosity bone cement for use in total hip replacement

2

Palacos R

Group Type: ACTIVE_COMPARATOR

Palacos R

Intervention Type: DEVICE

A high viscosity bone cement for use in total hip replacement

Interventions

Acryloc™ GHV

A high viscosity bone cement for use in total hip replacement

Intervention Type: DEVICE

Palacos R

A high viscosity bone cement for use in total hip replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects with non-inflammatory arthritis of the hip.

v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.

vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects undergoing corticosteroid treatment.

vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Trondheim

Trondheim, Sor-Trondelag, Norway

Countries

Norway

Other Identifiers

CT02/08

Identifier Type: -

Identifier Source: org_study_id